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NCT05407662 · ClinicalTrials.gov registry record
A Study Using Surveys to Learn More About Treatment With Steroidal Mineralocorticoid Receptor Antagonists, How They Are Used, What Side Effects They Have, and How Satisfied People Who Receive Them Are in the US
A clinical trial, sponsored by Bayer.
- Completed
- Registry status
- 600
- Enrollment target
NCT05407662: Completed study, sponsored by Bayer.
NCT05407662 is a clinical trial that has completed, run by Bayer. The registered enrollment target is 600 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05407662 has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- 600 participants
- Enrollment target
Study Summary
This is an observational study in which patients with chronic kidney diseases (CKD), type 2 diabetes (T2D) or heart failure (HF) who are current or past users of sMRA therapies are studied. sMRA stands for steroidal mineralocorticoid receptor antagonists. CKD is a long-term, progressive decrease in the kidneys' ability to work properly. Type 2 diabetes is a condition in which the body does not make enough of a hormone called insulin or does not use insulin well resulting in high blood sugar levels. HF is a condition in which the heart does not pump blood as well as it should. The renin-angiotensin-aldosterone system (RAAS) is a hormone system that works with the kidneys to control blood pressure and the balance of fluid and electrolytes (like salt) in the blood. The RAAS has been a treatment target of heart and kidney diseases for decades. One of these classes of medications is called mineralocorticoid receptor (MR) antagonists (MRAs). MRAs work to directly block the action of a hormone called aldosterone. Aldosterone is produced naturally by the adrenal glands, and it can increase the blood volume and blood pressure. Using MRAs therapies can help prevent strokes, heart attacks and kidney problems. Spironolactone was the first available MRA in the US with its approval in 1960. Eplerenone is another MRA which has been available since 2002. Both spironolactone and eplerenone are known as steroidal MRA (sMRA) due to their chemical structures. The main purpose of this study is to collect more data on the characteristics of patients who are taking sMRA currently and those who have discontinued sMRA therapy in the past 12 months. To do this, patients who have received sMRA in the most recent 12 months will be invited to participate in the study and asked to complete surveys if they agree to join the study. Patients will be found from administrative claims in a database called HealthCore Integrated Research Database (HIRD). And the other purposes of the study are t
Primary Outcome
sMRA stands for steroidal mineralocorticoid receptor antagonists.
Interventions
- OTHER sMRA therapies
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2022-11-02 |
| Est. Completion | 2023-06-13 |
What the finished NCT05407662 record still lists
NCT05407662 is an observational study that tracks outcomes without assigning an intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which sMRA therapies is the first listed.
NCT05407662 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05407662 about?
NCT05407662 is a clinical study titled "A Study Using Surveys to Learn More About Treatment With Steroidal Mineralocorticoid Receptor Antagonists, How They Are Used, What Side Effects They Have, and How Satisfied People Who Receive Them Are in the US". This is an observational study in which patients with chronic kidney diseases (CKD), type 2 diabetes (T2D) or heart failure (HF) who are current or past users of sMRA therapies are studied. sMRA stands for steroidal mineralocorticoid receptor antagonists. CKD is a long-term, progressive decrease in...
What is the current status of trial NCT05407662?
This trial is currently completed. The enrollment target is 600 participants. The study started on 2022-11-02. Estimated completion is 2023-06-13.
What interventions are being tested in trial NCT05407662?
The interventions under investigation include: sMRA therapies (OTHER).
Who is sponsoring clinical trial NCT05407662?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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